A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT04503265|
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Neoplasm Breast Cancer Ovarian Cancer Homologous Recombination Deficiency||Drug: AMXI-5001:Dose Escalation Phase I Drug: AMXI-5001: Dose Expansion Phase II||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies|
|Actual Study Start Date :||August 12, 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: AMXI-5001 Treatment
Single Arm Study, all participants will receive AMXI-5001.
Drug: AMXI-5001:Dose Escalation Phase I
Approximately 18-30 participants will be enrolled. Results from up to six (6) sequential groups will determine the Maximum Tolerated Dose and Recommended Phase II daily dose in the treatment of various cancers.
AMXI-5001 is administered orally twice daily, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule.
Drug: AMXI-5001: Dose Expansion Phase II
To further characterize the safety and clinical efficacy of AMXI-5001 at the Recommended Phase II Dose (RP2D), approximately 40 participants with HRD mutations will be enrolled in one of two cohorts based on their tumor type, HRD mutation, and prior treatment with PARP inhibitors.
AMXI-5001 is administered orally twice daily, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.
- Determine dose-limiting toxicity (DLT) [ Time Frame: Approximately 12 months ]Determine the DLT of AMXI-5001 (in milligrams)
- Determine Objective Response Rate (ORR) [ Time Frame: Approximately 24 months ]Determine ORR as a percent of participants with Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria relative to the efficacy population.
- Determine Duration of Response (DOR) [ Time Frame: Approximately 24 months ]Determine DOR as the time from documentation of tumor response to disease progression.
- Determine Progression-free Survival (PFS) [ Time Frame: Approximately 24 months ]Determine PFS as the time from study enrollment until objective tumor progression or death.
- Determine Overall Survival (OS) [ Time Frame: Approximately 24 months ]Determine OS as the time from study entry to death from any cause.
- Measure concentration of AMXI-5001 in plasma samples [ Time Frame: Approximately 24 months ]Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters will be calculated.
- Characterize safety profile of AMXI-5001 [ Time Frame: Approximately 24 months ]Characterize the safety profile of AMXI-5001 by incidence of treatment emergent adverse events, standard hematologic, chemistry, and ECG measurements.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503265
|Contact: Bonnie Wettersten, MS||(847) firstname.lastname@example.org|
|United States, California|
|UCLA Department of Medicine - Hematology/Oncology||Recruiting|
|Los Angeles, California, United States, 90404|
|United States, Florida|
|Moffitt Cancer Center and Research Institute||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|United States, Tennessee|
|The Sarah Cannon Research Institute/Tennessee Oncology||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Robert Reder, MD||AtlasMedx, Inc|